nonablative fractional diode laser for treatment of pigmented lesions

Conditions: Pigmented Skin Lesion

Summary: this study is being conducted to evaluate the safety and efficacy of a fractional diode laser for treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sunspots), and ephelides (freckles).

prospective, open-label, clinical trial to study the effects of the nonablative, fractional diode laser for treatment of pigmented lesions. up to 60 eligible participants will be enrolled at up to five (5) sites. participants will receive up to three (3) treatments in the following treatment areas: face, hands, arms, back, chest, or legs. participants will complete follow-up visits for clinical evaluation and photography at 1 and 3 months after the final study treatment.

Eligibility criteria:
inclusion criteria: 1. male or female 2. age 21 to 70 3. fitzpatrick skin type i to vi 4. willingness to have test spots and up to three (3) treatments for pigmented lesions on or off the face which are rated at baseline as moderate or higher per investigator or study staff 5. provide signed informed consent to participate in the study 6. adhere to study treatment and follow-up schedules 7. willing to have hair removed from the intended treatment area prior to treatment and/or photography 8. avoid sun exposure to all treated areas and use of sunscreen with sun protection factor (spf) 30 or greater throughout the duration of the study 9. adhere to post-treatment care instructions 10. allow photography of treated areas and to release their use for scientific and/or promotional purposes exclusion criteria: 1. pregnant, planning to become pregnant, or breast feeding during the study 2. allergy to lidocaine or similar medications 3. excessively tanned skin in the intended treatment area 4. open wound or infection in the intended treatment area 5. tattoo(s) or permanent make-up in the intended treatment area 6. skin condition in the intended treatment area that could interfere with treatment or evaluation of safety or efficacy 7. presence or history of melasma 8. presence or history of skin cancer within the treatment area 9. history of keloid or hypertrophic scar formation 10. history of herpes simplex virus (hsv) or similar condition in the intended treatment area unless treated with prophylactic medication 11. diagnosed coagulation disorder 12. immunosuppression disorder 13. presence of any medical condition that in the opinion of the investigator could impair healing or outcome as a result of treatment 14. use of systemic retinoid therapy (e.g. accutane) during the past six (6) months 15. use of topical retinoid therapy in the intended treatment area during the past two (2) weeks 16. use of oral corticosteroid therapy during the past four (4) weeks 17. prior treatment, such as surgery, light, laser or radiofrequency (rf) procedures in the intended treatment area during the past three (3) months 18. prior injectable dermal fillers (e.g. collagen, hyaluronic acid) in the intended treatment area within the past 12 months 19. prior injectable toxins (e.g. botox) in the intended treatment area within the past three (3) months 20. subjects who in the opinion of the investigator are unwilling or unable to adhere to the study requirements, or who are otherwise not a good candidate for the study